NCT04360707

Brief Summary

Patients with comorbid condition are known to be at high risk of severe forms of Covid-19. It is highly probable that immunocompromised patients like solid organ transplant (SOT) recipients are also at risk of severe forms of Covid-19. For this purpose, The investigators conducted a nationwide multicentric and multiorgan Registry to collect data about all French SOT recipients who develop a SARS-CoV-2 infection. The aim is to describe the clinical, biological and virological characteristics of these patients and to give information about evolution and prognosis of these particular population

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2021

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 22, 2020

Last Update Submit

April 30, 2020

Conditions

Keywords

SARS-CoV-2Covid-19Solid Organ transplantationIncidencePrognosisCellular responseHumoral Response

Outcome Measures

Primary Outcomes (1)

  • Clinical Presentation and Incidence of Covid-19 Infection in Different Cohorts of Solid Organ Transplant Patients

    From 1st March 2020 to 1st March 2021

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection

You may qualify if:

  • All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection
  • Adult and pediatric

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Néphrologie et Transplantation

Strasbourg, 67091, France

RECRUITING

Related Publications (1)

  • Gerard AO, Barbosa S, Anglicheau D, Couzi L, Hazzan M, Thaunat O, Blancho G, Caillard S, Sicard A; French SOT COVID Registry. Association Between Maintenance Immunosuppressive Regimens and COVID-19 Mortality in Kidney Transplant Recipients. Transplantation. 2022 Oct 1;106(10):2063-2067. doi: 10.1097/TP.0000000000004254. Epub 2022 Jul 27.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sophie CAILLARD, MD, PhD

    Service de Néphrologie et Transplantation

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

April 8, 2020

Primary Completion

April 8, 2021

Study Completion

April 8, 2021

Last Updated

May 5, 2020

Record last verified: 2020-04

Locations